LeMaitre 5F Plus Over the Wire Embolectomy Catheter — Class I medical device recall Z-1567-2020
Ongoing recall by LeMaitre Vascular, Inc., reported 2020-04-08, distributed nationwide. There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately
| Recall number | Z-1567-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2020-03-23 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CH, CO, CR, CZ, DE, DO, EE, EG, ES, FI, FR, GB, HU, IE, IL, IT, JP, KR, NL, NO, NZ, PL, PT, QA, SA, SE, SG, SI, SV, TH, TW, VN, ZA |
| Quantity | 43,315 |
| Lot numbers | OTW4180, OTW4187, OTW4198, OTW4202, OTW4218, OTW4246 |
| Model numbers | 1651-84, 1651-88, E1651-84, E1651-88 |
Product
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
Reason for recall
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1567-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.